ACTOS (pioglitazone hydrochloride) – Potential Association with Bladder Cancer – For the Public

Starting date:

April 19, 2012

Posting date:

April 19, 2012

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-190001046

This is duplicated text of a letter from Takeda Canada, Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Notice to Hospitals – Health Canada Endorsed Important Safety Information on ACTOS (pioglitazone hydrochloride)

April 19, 2012

Subject: Potential association between ACTOS (pioglitazone hydrochloride) and bladder cancer

Takeda Canada, Inc. in collaboration with Health Canada, would like to inform you about new safety information regarding ACTOS and a potential risk of bladder cancer in treated patients. Further to Health Canada’s assessment of safety data, the Product Monograph (PM) was updated to reflect this risk.

ACTOS (pioglitazone hydrochloride) is an antidiabetic medication authorized in Canada to control blood sugar levels in people with type 2 diabetes whose blood sugar levels have not been controlled by diet and exercise. ACTOS may be used alone or in combination with other diabetes drugs (sulfonylurea or metformin).

• New findings reveal that there is a potential increased risk of bladder cancer in patients treated with ACTOS.
  
   
• ACTOS should not be used if patients:
  • have or have had bladder cancer
  • have blood or a red colour in their urine
    
     
• Blood or a red colour in urine should be investigated before starting pioglitazone therapy. Patients prescribed pioglitazone are also advised to seek medical attention if during treatment, they have blood or a red colour in their urine, an increased need to urinate, or pain while they urinate, as these may be symptoms of bladder cancer.
  
   
• Risk factors for bladder cancer should be assessed before starting pioglitazone (risks include age, smoking, family history of bladder cancer, exposure to chemicals in the workplace, to certain cancer treatments and radiation therapy).

Available data reveal an association with a potential increased risk of bladder cancer in diabetic patients treated with pioglitazone in particular in patients treated for the longest durations and with the highest total doses. A possible risk after short term treatment cannot be excluded.

A five-year report of an ongoing 10-year study in patients with diabetes (KPNC study) suggested that taking pioglitazone longer than

12 months increased the risk of developing bladder cancer. There was an increase of 3 cases in 10,000 from approximately 7 in 10,000 (without pioglitazone) to approximately 10 in 10,000 (with pioglitazone).

Takeda Canada, Inc.has worked with Health Canada to update the safety information for ACTOS and has sent a letter to health care professionals to inform them of this new safety information. A copy of that letter is available on the Healthy Canadians website^Footnote1.

The newly revised Product Monograph for ACTOS (pioglitazone hydrochloride) can be accessed on the Web Sites of Health Canada^Footnote2 and Takeda Canada, Inc^Footnote3. Takeda Canada, Inc. will continue to review new safety data for ACTOS, including post-marketing adverse event reports.

Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Any case of unexpected adverse reactions in patients receiving ACTOS should be reported to Takeda Canada, Inc. or Health Canada at the following addresses:

Takeda Canada, Inc.

435 North Service Road West

Oakville, ON L6M 4X8

Telephone: 1-888-825-3321

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at MedEffect™ Canada
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    
    Health Canada
    
    Postal Locator 0701E
    
    Ottawa, Ontario K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

For other health product inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: MHPD_DPSC.public@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Sincerely,

original signed by

Dr. Brad Pamenter

Vice President, Medical and Scientific Affairs

Takeda Canada, Inc.

ACTOS is a trademark of Takeda Pharmaceutical Company Limited used under license by Takeda Canada, Inc.